Internet-based cognitive therapy for women with antenatal depressive symptoms during the COVID-19 pandemic: protocol for a multi-center randomized controlled trial across China
Abstract Background Depression and anxiety are common among pregnant women. Internet-delivered psychological therapies such as cognitive behavioral therapy (iCBT) have been developed to increase accessibility and address common help-seeking barriers, especially during pandemic period. The objective...
| Main Authors: | , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2022-09-01
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| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-022-06728-5 |
| _version_ | 1811208660567719936 |
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| author | Chen-Chi Duan Jia-Le Yu Jing Tao Chen Zhang Dan Zhang Xiu Zeng Wan-Ting Zeng Hua-Lin Xu Jian-Yin Qiu Cindy-Lee Dennis Li Jin He-Feng Huang Yan-Ting Wu |
| author_facet | Chen-Chi Duan Jia-Le Yu Jing Tao Chen Zhang Dan Zhang Xiu Zeng Wan-Ting Zeng Hua-Lin Xu Jian-Yin Qiu Cindy-Lee Dennis Li Jin He-Feng Huang Yan-Ting Wu |
| author_sort | Chen-Chi Duan |
| collection | DOAJ |
| description | Abstract Background Depression and anxiety are common among pregnant women. Internet-delivered psychological therapies such as cognitive behavioral therapy (iCBT) have been developed to increase accessibility and address common help-seeking barriers, especially during pandemic period. The objective of this trial is to evaluate the short-term and long-term effects of iCBT on reducing depressive symptoms among pregnant women during the COVID-19 pandemic with the overall goal of preventing depression recurrence in the first 12 months postpartum. Methods A multi-site randomized controlled trial will be conducted where 300 pregnant women early in their third trimester will be screened for depression symptoms using the Edinburgh Postnatal Depression Scale (EPDS) during a routine obstetrical visit. Eligible and consenting women with a score greater than 9 will be randomly allocated (1:1) to either intervention group or control group. ICBT involving the completion of 7 weekly online modules will be delivered via a well-designed perinatal mental healthcare app. The primary objective is to evaluate the effect of iCBT on reducing depression symptoms among pregnant Chinese women starting from their third trimester. The secondary objectives are to examine the effect of iCBT on anxiety, sleep quality, social support, parenting stress, co-parenting relationship, and infant development. Discussion This multi-center randomized controlled trial has been planned in accordance with best practices in behavioral trial design. The internet-based intervention addressed the needs of pregnant women during a major pandemic where face-to-face therapy is not preferable. The trial has a relatively large sample size with sufficient power to evaluate the efficacy of iCBT intervention for the primary and secondary outcomes. One year follow-up evaluation in the study is designed to determine the longer-term effect of the intervention on both maternal and infant outcomes. Although a limitation is the assessment of depression and anxiety using self-report measures, these easily incorporated and maternal-preferred assessments allow for real-life scalability if the intervention is proven to be effective. Ethics and dissemination Ethics was approved by the institutional review board of International Peace Maternity and Child Health Hospital (GKLW2020-25). Dissemination of results will be published in peer-reviewed academic journals and presented at scientific conferences. Trial status The first patient was enrolled on 19 August 2020. To date, 203 participants have met eligibility requirements and been randomized to either the intervention group or control group. Data collection aims to be complete in September 2022. Date and version identifier: 2020715-version1.0. Trial registration ChiCTR2000033433. Registered 31 May 2020, http://www.chictr.org.cn/showproj.aspx?proj=54482 . |
| first_indexed | 2024-04-12T04:25:20Z |
| format | Article |
| id | doaj.art-21cb49cfd32740f5aabf852817ac3da0 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-12T04:25:20Z |
| publishDate | 2022-09-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-21cb49cfd32740f5aabf852817ac3da02022-12-22T03:48:06ZengBMCTrials1745-62152022-09-0123111010.1186/s13063-022-06728-5Internet-based cognitive therapy for women with antenatal depressive symptoms during the COVID-19 pandemic: protocol for a multi-center randomized controlled trial across ChinaChen-Chi Duan0Jia-Le Yu1Jing Tao2Chen Zhang3Dan Zhang4Xiu Zeng5Wan-Ting Zeng6Hua-Lin Xu7Jian-Yin Qiu8Cindy-Lee Dennis9Li Jin10He-Feng Huang11Yan-Ting Wu12Obstetrics and Gynecology Hospital, Institute of Reproduction and Development, Fudan UniversityResearch Units of Embryo Original Diseases, Chinese Academy of Medical Sciences (No. 2019RU056)Shanghai Mental Health Center, School of Medicine, Shanghai Jiao Tong University School of MedicineObstetrics and Gynecology Hospital, Institute of Reproduction and Development, Fudan UniversityKey Laboratory of Reproductive Genetics and Department of Reproductive Endocrinology, Women’s Hospital, Zhejiang University School of MedicineHunan Maternal and Child Health Care HospitalHangzhou Women’s HospitalShaoxing Maternity and Child Health Care HospitalShanghai Mental Health Center, School of Medicine, Shanghai Jiao Tong University School of MedicineLawrence S. Bloomberg Faculty of Nursing, University of TorontoObstetrics and Gynecology Hospital, Institute of Reproduction and Development, Fudan UniversityObstetrics and Gynecology Hospital, Institute of Reproduction and Development, Fudan UniversityObstetrics and Gynecology Hospital, Institute of Reproduction and Development, Fudan UniversityAbstract Background Depression and anxiety are common among pregnant women. Internet-delivered psychological therapies such as cognitive behavioral therapy (iCBT) have been developed to increase accessibility and address common help-seeking barriers, especially during pandemic period. The objective of this trial is to evaluate the short-term and long-term effects of iCBT on reducing depressive symptoms among pregnant women during the COVID-19 pandemic with the overall goal of preventing depression recurrence in the first 12 months postpartum. Methods A multi-site randomized controlled trial will be conducted where 300 pregnant women early in their third trimester will be screened for depression symptoms using the Edinburgh Postnatal Depression Scale (EPDS) during a routine obstetrical visit. Eligible and consenting women with a score greater than 9 will be randomly allocated (1:1) to either intervention group or control group. ICBT involving the completion of 7 weekly online modules will be delivered via a well-designed perinatal mental healthcare app. The primary objective is to evaluate the effect of iCBT on reducing depression symptoms among pregnant Chinese women starting from their third trimester. The secondary objectives are to examine the effect of iCBT on anxiety, sleep quality, social support, parenting stress, co-parenting relationship, and infant development. Discussion This multi-center randomized controlled trial has been planned in accordance with best practices in behavioral trial design. The internet-based intervention addressed the needs of pregnant women during a major pandemic where face-to-face therapy is not preferable. The trial has a relatively large sample size with sufficient power to evaluate the efficacy of iCBT intervention for the primary and secondary outcomes. One year follow-up evaluation in the study is designed to determine the longer-term effect of the intervention on both maternal and infant outcomes. Although a limitation is the assessment of depression and anxiety using self-report measures, these easily incorporated and maternal-preferred assessments allow for real-life scalability if the intervention is proven to be effective. Ethics and dissemination Ethics was approved by the institutional review board of International Peace Maternity and Child Health Hospital (GKLW2020-25). Dissemination of results will be published in peer-reviewed academic journals and presented at scientific conferences. Trial status The first patient was enrolled on 19 August 2020. To date, 203 participants have met eligibility requirements and been randomized to either the intervention group or control group. Data collection aims to be complete in September 2022. Date and version identifier: 2020715-version1.0. Trial registration ChiCTR2000033433. Registered 31 May 2020, http://www.chictr.org.cn/showproj.aspx?proj=54482 .https://doi.org/10.1186/s13063-022-06728-5Antenatal depressionCognitive behavior therapyInternetPsychological distressAnxietyCOVID-19 |
| spellingShingle | Chen-Chi Duan Jia-Le Yu Jing Tao Chen Zhang Dan Zhang Xiu Zeng Wan-Ting Zeng Hua-Lin Xu Jian-Yin Qiu Cindy-Lee Dennis Li Jin He-Feng Huang Yan-Ting Wu Internet-based cognitive therapy for women with antenatal depressive symptoms during the COVID-19 pandemic: protocol for a multi-center randomized controlled trial across China Trials Antenatal depression Cognitive behavior therapy Internet Psychological distress Anxiety COVID-19 |
| title | Internet-based cognitive therapy for women with antenatal depressive symptoms during the COVID-19 pandemic: protocol for a multi-center randomized controlled trial across China |
| title_full | Internet-based cognitive therapy for women with antenatal depressive symptoms during the COVID-19 pandemic: protocol for a multi-center randomized controlled trial across China |
| title_fullStr | Internet-based cognitive therapy for women with antenatal depressive symptoms during the COVID-19 pandemic: protocol for a multi-center randomized controlled trial across China |
| title_full_unstemmed | Internet-based cognitive therapy for women with antenatal depressive symptoms during the COVID-19 pandemic: protocol for a multi-center randomized controlled trial across China |
| title_short | Internet-based cognitive therapy for women with antenatal depressive symptoms during the COVID-19 pandemic: protocol for a multi-center randomized controlled trial across China |
| title_sort | internet based cognitive therapy for women with antenatal depressive symptoms during the covid 19 pandemic protocol for a multi center randomized controlled trial across china |
| topic | Antenatal depression Cognitive behavior therapy Internet Psychological distress Anxiety COVID-19 |
| url | https://doi.org/10.1186/s13063-022-06728-5 |
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